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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG

Germany · Karlsruhe

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

7listed device types

Class I 0Class II 3Class III 4

plus 12 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

12 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

19active device licences

Class II 11Class III 6Class IV 2

59 including historic records

TWTaiwanTFDA

14valid device licences

Class I 3Class II 9Class III 2

SGSingaporeHSA SMDR

2device registrations

CLASS C 1CLASS D 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

7active ARTG entries

Class I 1Class III 3IIb 3

HKHong KongMDACS

6valid listings

Class III 5Class IV 1

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

9active registrations

Class 2a 1Class 2b 3Class 3 5

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States12 registration records, 1 510(k), 0 PMA, 1 excluded

Brazil2 confirmed, 1 excluded

Canada19 confirmed, 0 excluded

Manufacturer names merged into this page: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG

FDA 510(k) clearances by year

11992 · K912892

FDA listed device types

Stent, Ureteral 1Dislodger, Stone, Basket, Ureteral, Metal 1Stents, Drains And Dilators For The Biliary Ducts 1Stent, Iliac 1Stent, Superficial Femoral Artery 1System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment 1Stent, Iliac Vein 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K912892	AUTO-VAC BIOPSY NEEDLE	1992-02-07
BR	80689090064	HIGHFLEX BASKET	Class II
BR	80689099013	Highflex	Class II
CA	6402	ACCUREXX COLORECTAL STENT	Class III
CA	6874	SOFT DRAIN NEPHROSTOMY SETS	Class II
CA	7988	ZEISS LOOP CATHETER	Class II